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| Name | Class |
|---|---|
| Sociedad Argentina de Diabetes | UNKNOWN |
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Gestational diabetes mellitus (GDM) is associated to adverse maternal and neonatal outcomes. The aim of this study is to address whether the addition of extra virgin olive oil to the diet of women with GDM improves maternal triglyceridemia and reduces insulin requirement and diagnosis of diabetes at postnatal reclassification.
This study is a randomized trial in which 1200 pregnant women at GDM diagnosis from 16 health care centers will be recruited and randomized in two parallel arms: 1 World Health Organization (WHO)-diet supplemented with 3 tablespoons of Extra Virgin Olive Oil (Intervention Group, n=600); 2. WHO-diet with no Extra Virgin Olive Oil supplementation (Control Group, n=600). Expected results: the investigators expect that the intervention will contribute to improve maternal lipid profile, reduce insulin requirement and reduce maternal diagnosis of diabetes at postpartum reclassification. Thus, this study is expected to identify maternal beneficial effects of this dietary intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary addition of extra virgin olive oil | Experimental | WHO diet with a daily addition of extra virgin olive oil |
|
| No addition of extra virgin Olive Oil | No Intervention | WHO diet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extra Virgin Olive Oil Addition | Dietary Supplement | Daily dietary addition of olive oil (three tablespoons) |
|
| Measure | Description | Time Frame |
|---|---|---|
| maternal triglyceridemia | triglycerides in mg/dl | term pregnancy |
| maternal weight gain | gestational maternal weight gain in kg | change from prepregnancy weight to term pregnancy weight |
| number of participants with insulin requirement | insulin use | term pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| number of participants with diabetes at postpartum | maternal diagnosis of diabetes at postpartum | six weeks postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad Patagonica de Medicina Maternofetal y Embarazo de Alto Riesgo | Neuquén | Neuquén Province | Q8300BCI | Argentina |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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Dietary intervention study: GDM patients receiving a WHO diet with or without addition of extra virgin olive oil
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Data analysis will be masked
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |